You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 7, 2025

Patent: 8,632,770


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 8,632,770
Title:Glycopegylated factor IX
Abstract:The present invention provides conjugates between Factor IX and PEG moieties. The conjugates are linked via an intact glycosyl linking group interposed between and covalently attached to the peptide and the modifying group. The conjugates are formed from glycosylated peptides by the action of a glycosyltransferase. The glycosyltransferase ligates a modified sugar moiety onto a glycosyl residue on the peptide. Also provided are methods for preparing the conjugates, methods for treating various disease conditions with the conjugates, and pharmaceutical formulations including the conjugates.
Inventor(s):DeFrees Shawn, Bayer Robert J., Bowe Caryn, Panneer-Selvam Krishnasamy
Assignee:Novo Nordisk A/S
Application Number:US12851651
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 8,632,770

Introduction

Patent 8,632,770, like any other patent, is a complex document that requires a thorough analysis to understand its claims, validity, and position within the broader patent landscape. This analysis will delve into the key aspects of patent quality, the statutory requirements for patentability, and the current challenges and recommendations for improving the U.S. patent system.

Understanding Patent Quality

Patent quality is a critical factor in the U.S. patent system. The U.S. Patent and Trademark Office (USPTO) has been working to improve patent quality through various initiatives, including the Enhanced Patent Quality Initiative. However, a consistent definition of patent quality remains elusive. Stakeholders generally agree that a quality patent should meet statutory requirements for novelty, clarity, and non-obviousness, and should be upheld if challenged[1].

Statutory Requirements for Patentability

To obtain a patent in the United States, an invention must satisfy several statutory requirements outlined in Title 35 of the United States Code. These include novelty (Section 102), non-obviousness (Section 103), and subject matter eligibility (Section 101). The latter has been particularly contentious, especially following the Supreme Court's decision in Alice v. CLS Bank, which introduced a two-part test for determining patentable subject matter[2].

Claims Analysis

A well-written patent application, such as the one for Patent 8,632,770, should describe the invention in a manner that one of ordinary skill in the field can understand and replicate. The claims must be particularly pointed out and distinctly defined, avoiding issues under 35 USC ยง112(b)[3].

Claim Clarity and Scope

Claims should be narrow enough to avoid prior art but broad enough to prevent design-around strategies. The use of clear and specific language is crucial to avoid ambiguity and ensure that the claims are enforceable. For example, defining special claim terms explicitly ("As used herein, term X means Y") helps in claim interpretation and avoids potential disputes[3].

Claim Structure

The structure of claims is also important. Each claim should include a preamble, a transitional phrase, and a body that clearly defines the invention. This structure helps in ensuring that the claims are clear and distinct, which is essential for patent validity and enforceability[3].

Patent Landscape and Challenges

The U.S. patent landscape is complex and evolving, with several challenges affecting patent holders and applicants.

Patent Eligibility

The subject matter eligibility requirement under Section 101 has been a significant source of uncertainty. The Alice v. CLS Bank decision created a two-part test that has been difficult to apply, leading to unpredictability for innovators and investors. Efforts to clarify these requirements, such as the proposed Patent Eligibility Restoration Act of 2022, are ongoing but have not yet been successful[2].

Patent Enforceability

Even when a patent is granted, enforcing it can be challenging. The Leahy-Smith America Invents Act of 2011 introduced administrative procedures like inter partes review and post-grant review, which have made it easier for third parties to challenge patent validity. This has led to concerns that the current system undermines the U.S. patent system by allowing repeated attacks on the same patent[2].

Role of AI in Patent Drafting

The increasing use of AI tools in patent drafting introduces new risks and considerations. AI can assist in identifying evidence and drafting portions of the specification and claims, but practitioners must ensure that these contributions do not introduce inaccuracies or omit material information. The USPTO has issued guidance to help practitioners mitigate these risks and ensure compliance with legal standards[5].

Public Data and Transparency

To strengthen the intellectual property system, there is a need for more transparent and accessible data. Legislation has been proposed to require the USPTO to issue reports on the data it collects and make this data available to the public. This would allow outside researchers to conduct analyses and provide insights into patent disparities and other issues within the system[2].

Application Readiness and Compact Prosecution

The quality of the patent application at the time of submission is crucial for efficient and effective prosecution. The USPTO has developed tools like the Application Readiness Review Form (ARRF) to assess whether an applicant has provided sufficient information. This helps in identifying application characteristics that impact quality and pendency, and in making data-driven decisions to improve the patent process[1].

Key Takeaways

  • Patent Quality: A consistent definition of patent quality is essential for measuring progress and improving the patent system.
  • Statutory Requirements: Inventions must meet novelty, non-obviousness, and subject matter eligibility requirements.
  • Claim Clarity: Clear and distinct claims are critical for patent validity and enforceability.
  • Patent Landscape: Challenges include unclear subject matter eligibility, difficulties in enforcing patents, and the impact of AI on patent drafting.
  • Transparency and Data: Public access to patent data can enhance the system by providing insights into disparities and inefficiencies.

FAQs

  1. What are the key statutory requirements for patentability in the United States?

    • The key requirements include novelty (Section 102), non-obviousness (Section 103), and subject matter eligibility (Section 101) under Title 35 of the United States Code[2].
  2. How does the USPTO measure patent quality?

    • The USPTO uses correctness measures and quantifiable compliance targets, such as statutory compliance rates for various sections of Title 35, to measure patent quality[1].
  3. What is the impact of AI on patent drafting?

    • AI can assist in drafting but must be used carefully to avoid introducing inaccuracies or omitting material information. Practitioners must verify the accuracy of all documents prepared with AI assistance[5].
  4. Why is patent enforceability a challenge in the U.S.?

    • Patent enforceability is challenging due to the ease of challenging patents through administrative procedures like inter partes review and post-grant review, which can lead to repeated attacks on the same patent[2].
  5. What steps can be taken to improve the U.S. intellectual property system?

    • Steps include clarifying patent eligibility requirements, strengthening patent enforceability, improving transparency and data access, and addressing the role of AI in patent drafting[2].

Sources

  1. GAO Report: Intellectual Property: Patent Office Should Define Quality, Reassess ...
  2. CSIS Analysis: Four Actions to Strengthen the U.S. Intellectual Property System
  3. USPTO Guide: Drafting a Provisional Application
  4. National Archives: Records of the Patent and Trademark Office
  5. BIPC: U.S. Patent Office Issues Additional Guidance on Use of AI Tools

More… ↓

⤷  Subscribe

Details for Patent 8,632,770

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novo Nordisk Inc. REBINYN coagulation factor ix (recombinant), glycopegylated For Injection 125611 May 31, 2017 8,632,770 2030-08-06
Novo Nordisk Inc. REBINYN coagulation factor ix (recombinant), glycopegylated For Injection 125611 August 11, 2022 8,632,770 2030-08-06
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.